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On March 13, 2017, the board of directors of Agencia Nacional De Vigilancia Sanitari’s (ANVISA) announced that they had reached a new agreement with the Brazilian Patent Office, namely, the Instituto Nacional da Propriedade Industrial (INPI), concerning the prior approval provision under Article 229-C of the Brazilian Patent Statute (For more information about the 229-C article, please see our posts here, here, and here). On April 12, 2017, after an event with several authorities and President Michel Temer, ANVISA and INPI published a written version of the new joint guidelines #1/2017 (translation enclosed here:INTERAGENCY ORDINANCE). These guidelines describe the new workflow between ANVISA and INPI involving the examination of pharmaceutical patent applications.

Article 4 of the guidelines establishes that ANVISA will analyze whether a patent application is contrary to public health.According to Article 4, a patent application claiming a product or process is considered to be contrary to public health when the product or process presents a “health risk”.The article further states that the “health risk” will be characterized when the pharmaceutical product comprises, or the pharmaceutical process results in a substance that has been prohibited in the country”.

If a product or process is found to pose a “health risk” (as defined in the Annex I of the Ministry of Health’s Ordinance #344 of 1998), ANVISA will deny prior approval and will send the application back to INPI for further handling. At this point, INPI will publish the definitive dismissal of the application. In other words, the application is denied.

The guidelines contain a new approach in the examination of patent applications claiming pharmaceutical products and processes of interest under the Brazilian government’s drug policies and pharmaceutical assistance of the National Healthcare System (SUS). Under Article 5, ANVISA will examine these applications of interest and prepare a “technical” opinion as to whether the claims meet the patentability requirements under Brazilian law.This opinion will be sent to INPI for use as a third-party observation under Article 31 of the Patent Statute of 1996.Once INPI receives ANVISA’s opinion, it is “free” to decide whether or not to agree with it. In the event INPI disagrees with ANVISA’s opinion and grants the patent application, it will send ANVISA a list containing all granted patents and will continue to make this list available to ANVISA (Article 7 of the guidelines).

The guidelines do not contain any information as to what ANVISA can or should do with the list of granted patents received from INPI.Actions that ANVISA could take include filing a post-grant opposition or seeking invalidity of the patent before Federal Courts.

Article 9 of the guidelines creates an Interagency Group between the two agencies. The purpose of this group is to seek to “harmonize” the understanding between the ANVISA and INPI regarding the application of patent law in “polemic” topics such as Markush claiming, selection inventions, the patentability of new uses, salts, polymorphs and antibodies, as well as other issues relevant to the pharmaceutical industry.One concern is that such “harmonization” could result in an unlawful administrative ban of claims that are currently being allowed INPI. As such, Article 9 gives ANVISA power to influence the INPI in a multitude of ways.

Additionally, it is important to note that the new guidelines come after several decisions were obtained against ANVISA by various pharmaceutical companies (See our post here) holding that that the agency lacked the statutory authorization to examine patentability requirements under Brazilian law. After these early decisions were rendered (which held that ANVISA’s prior approval review was restricted solely to the analysis of potential public health issues and not patentability requirements), ANVISA amended its guidelines to include a provision stating that “the granting of patents that do not fulfil the patentability requirements violates public health”. This change was interpreted by the courts as an attempt by the agency to escape the unfavorable case law and avoid the new guidelines.

As a whole, the guidelines read like an attempt by ANVISA to revive its ability to participate in the examination of pharmaceutical patent applications. Interestingly, many the associations representing generic companies in Brazil such as ABIFINA and Pro Generics are celebrating the guidelines as a victory for the local industry.

Continue to watch the BRIC Wall Blog for continuing updates on these new guidelines in Brazil.

This post was written by Lisa Mueller and Roberto Rodrigues Pinho from Licks Attorneys.

In the second half of 2016, two very interesting decisions were issued by the federal courts in Brazil against the Brazilian Food and Drug Agency (ANVISA) involving the prior approval of patent applications claiming pharmaceutical products.These decisions bring some very good news to pharmaceutical patent owners who have struggled for years with ANVISA while trying to protect their pharmaceutical patents in this country.

In the decisions, Genentech and Novartis each obtained preliminary injunctions against ANVISA in cases of prior approval of their patent applications under Article 229-C of the Brazilian Patent Statute (Additional information about each of the decisions can be found here:novartisdecisiongenentechdecision).Specifically, Novartis’ patent application claims fingolimod (Gilenya) and Genentech’s application claims bevacizumab (Avastin).

Two different trial judges affirmed that ANVISA did not have the authority to examine patentability requirements under Article 229-C of the Patent Statute. In the decision involving Genentech’s application, the judge, the Honorable Diana Silva, limited ANVISA’s role during the prior approval process to only aspects involving public health. The decision also stated that the Brazilian Patent and Trademark Office, namely, the Instituto Nacional da Propriedade Industrial (INPI)is the sole legitimate agency to examine the patentability requirements of patent applications directed to pharmaceutical products.

The decision involving Novartis’ application is an important case for pharmaceutical companies facing the issues of backlog and pendency of their patent applications in Brazil. Specifically, in this case, Novartis sought a preliminary injunction against ANVISA, claiming that the agency was taking an unreasonable amount of time to issue a decision regarding prior approval.Additionally, Novartis also requested preventive measures against the agency to prevent it from examining the application for compliance with patentability requirements under the Brazilian Patent Statute (which is the function of INPI).The judge, the Honorable Iolete Oliveira, accepted Novartis’ arguments and granted a preliminary injunction ordering ANVISA to:(1) analyze the prior approval of the patent application within 15 days; and (2) abstain from examining the application for compliance with any patentability requirements but focus instead only on aspects of public health.

Both of these decisions highlight that the Brazilian federal courts are willing to limit ANVISA’s role under the prior approval analysis. The Novartis case establishes important precedent that can be used by other companies currently waiting ANVISA’s decision on prior approval analysis.

It has been 13 years since the Brazilian Food and Drug Administration (ANVISA) updated the guidelines regulating which drugs can receive over-the-counter (OTC) status. The much-anticipated guidelines, which issued on August 3, 2016 as Rule #98, revoke the previous Rule #138, which was established in 2003. Rule #138 established which drugs could be sold as OTC medications, according to their therapeutic indications. Drugs currently recognized as safe for over-the-counter use under Rule #138 will continue to be categorized as such until a reassessment can be completed and compliance with Rule #98 evaluated; however the new guidelines allow ANVISA to simultaneously reassess the status of currently available OTC drugs while expanding the number of new products available to consumers.

Rule #98 was previously submitted to Public Inquiry #27 on April 8, 2015. According to ANVISA’s report on the public inquiry, the general feedback was that the new rule will have a positive impact on the market, especially with regards to increasing patient’s access to drugs and the recognition of pharmacists’ roles in healthcare. It is expected that Rule #98 will expand the number of OTC drugs in the Brazilian market, which will increase price competition and marketing efforts towards consumers, rather than physicians.

In order to be compliant with Rule #98, drugs must comply with the following seven criteria:

The drug must have been commercially available for a minimum of 10 years (five years in Brazil), as a prescription drug, or five years, as an OTC drug, in countries where regulations are similar to ANVISA.

The drug must exhibit a high level of safety: the causes of the adverse reactions must be well known and easily reversed, the drug must have a low level of toxicity, a safe therapeutic window, and a low level of interactions with other drugs and food.

The clinical condition treated by the drug cannot evolve rapidly, and its symptoms must be easily identifiable by the consumer.

The drug must pose a low risk when used off label or in overdose scenarios.

The drug cannot be indicated for continuous use; rather, it can only be used for a short period of time or a fixed period of time, which must be identified in the drug’s label (except for drugs labeled for prevention).

The consumer must be capable of using the drug without any physical assistance from a healthcare professional.

The drug cannot cause chemical dependency in consumers.

Companies looking to obtain OTC status for a particular drug can do so at any time; status can be applied for with the Marketing Approval Application, or after the drug has already been approved. The OTC status request must be supported by the required documents listed in Rule #98, ensuring compliance with the above-identified criteria. The company must also support its request with a risk reduction plan, which will inform the ANVISA how it will monitor occasional risks arising from the commercialization of the drug as an OTC product. Once the OTC status is approved, the decision will be published by ANVISA in the Official Gazette and be made available online. The publication will include the active pharmaceutical ingredients (API) in the drug. Once published, companies will have 180 days to make appropriate amendments to the drug packaging and label, as well as have the product sales status changed to OTC.

Importantly, Rule #98 defines which products are not entitled to receive OTC status, which includes drugs that require parenteral administration, or drugs that are commercially packaged, as the quantity of the API per package exceeds the maximum limits established by ANVISA.

The enforcement of Rule #98 will begin 30 days after its publication on September 3, 2016. Please continue to check the BRIC Wall Blog for additional updates on the enforcement of these new guidelines in Brazil.

In this post, the BRIC Wall Blog continues to examine the Office of the United States Trade Representative (USTR) 2016 Special 301 report (Report) reviewing the state of intellectual property rights (IPR) protection and enforcement in U.S. trading partners around the world. The Report details the results of extensive research and analysis, which led to placing eleven countries on the priority watch list and twenty-three on the watch list. Brazil remains on the Watch List in 2016.

Despite efforts to protect against online piracy, significant concerns remain over the high levels of piracy and counterfeiting in Brazil. In order to create public awareness and enact enforcement campaigns, the National Council on Combating Piracy and International Property Crimes (CNCP) was identified in past years as an effective entity for carrying out public awareness and enforcement campaigns. Unfortunately, the CNCP was underutilized and overall ineffective in 2015. In the Report, the United States urges Brazil to provide resources for intellectual property (IP) enforcement and seeks further commitments from the country on the strengthening of its IPR protection and enforcement measures.

The Report also addresses the continued problem of significant delays in the examination of patents and trademarks, which, on average, take about eleven and three years, respectively. In early 2016, the United States-Brazil Patent Prosecution Highway pilot program was enacted to expedite the patent examination process in Brazil, specifically for inventions related to the oil and gas sector. Despite this positive step forward, there is still a duplicative review of pharmaceutical patent applications by the National Sanitary Regulatory Agency (ANVISA) which lacks transparency, exacerbates delays of patent registrations for innovative medications, and prevents patent examination by the National Institute of Intellectual Property (INPI).

Furthermore, although there are laws and regulations in Brazil to protect veterinary and agricultural chemical products against unfair commercial use of undisclosed test data and other data generated to maintain marketing approval, these same laws and regulations do not apply to pharmaceutical products. Additionally, the Report notes that actions are being taken by INPI to invalidate or shorten the term of certain “mailbox” patents for pharmaceutical and agricultural chemical products. The Report concludes that the strengthening of IPR enforcement and protection for foreign and domestic right holders as well as expediting the examination of trademarks and patents is essential for continued innovation and investment in Brazil.

George Washington University Law School, Licks Attorneys, the Ministry of Foreign Affairs Department of Trade and Investment Promotion and the Embassy of Brazil in Washington D.C. are hosting a one day seminar on Thursday, May 12, 2016, in Washington D.C. entitled “Brazilian High-Tech Litigation: Law, Business & Policy”. Interesting topics to be covered include:

Brazilian PTO Examination Guidelines for Biotechnology Inventions

The role of Brazilian Courts in ensuring Compliance with TRIPS

Policy Making by Judicial Activism and the Judiciary’s Practice

Litigation in Brazil against the Government on behalf of foreign companies

The role of specialized IP Courts in the business environment

Litigating Standard Essential Patents

Pharmaceutical Litigation: BRPTO, ANVISA and infringers

Opportunities Created by Regulatory Developments for pharma, telecom and the internet

On June 5, 2015, the 13th Federal District Court of Rio de Janeiro invalidated Astrazeneca’s patent BR PI0003364-2 covering Crestor® (rosuvastatin). The Judge, the Honorable Marcia Nunes Barros, agreed with the arguments submitted by the Brazilian Patent Office and National Sanitary Vigilance Agency (ANVISA) that the patent was obvious over the prior art. The Honorable Barros is the same Judge that recently issued a decision holding that ANVISA was allowed to examine patentability requirements during prior approval/consent analysis under Article 229-C of the Patent Statute.

According to the decision, the use of the tribasic calcium phosphate to stabilize statins was expressly recommended in the prior art document PT 547 000E. Even though the use of the term “potentially” in the prior art did not denote certainty regarding stabilization, according to the Court, this meant that tribasic calcium phosphate was “probably useful for stabilizing statins”.

Additionally, although the prior art document recited a pH value of at least 8, preferably 9, for the stabilization of statins, the Court held that this pH value related to the stabilization of fluvastatin and not rosuvastatin. The Court referred to the Handbook of Pharmaceutical Excipients, which stated that tribasic calcium phosphate had a pH value of 6.8 at 20% solubility.

The Court held that a person of ordinary skill in the art (POSITA) would have known from PT 547 000E that tribasic calcium phosphate could be used to stabilize statins. Therefore, because the pH of a stabilizing agent varies based on concentration, a POSITA would have been motivated to investigate using tribasic calcium phosphate to stabilize a statin (in other words, it was “obvious to try”). The Court found this to be true because the pH value of 8 recited in PT 547 000E referred to the stabilization of a different statin (fluvastatin) and not rosuvastatin. Other prior art, such as WO 97/23200, described using a pH value of between 7.0 to 8.0 to stabilize the HMG-CoA inhibitor, E)-3,5-dihydroxy-7-[4′-4″-fluorophenyl-2′-cyclopropyl-quinolin-3′-yl]-6-heptenoic acid.

Therefore, according to the Court, a PHOSITA at the time of the invention would have understood that different statins required different pH values for stabilization. Even though tribasic calcium phosphate only had a pH value of 6.8 based on its solubility data, the Court held that a PHOSITA would have been motivated to test tribasic calcium phosphate as a stabilizing agent for rosuvastatin.

Interestingly, despite the fact that the court-appointed expert issued a report concluding that the patent was valid, the Judge mentioned international standards for assessing inventive step, including the U.S. Supreme Court’s decision in KSR Int’l Co. v. Teleflex, Inc., in concluding that the technical solution presented in the patent was obvious to try and that there was a reasonable expectation of success.

This post was written by Lisa Mueller and Roberto Rodrigues and Luiza Cotia of Licks Attorneys.

One of the most contentious issues in the Brazilian pharmaceutical landscape is role of National Sanitary Vigilance Agency (ANVISA) during the prior approval/consent analysis of patent applications claiming pharmaceutical inventions. Article 229-C of Brazil’s Patent Statute (Statute) provides that ANVISA shall have the right to provide approval of patent applications claiming pharmaceutical inventions (often referred to as “prior approval” or “prior consent”). Specifically, Article 229-C provides that: “The grant of patents for pharmaceutical products and processes shall depend upon the prior approval from the National Sanitary Vigilance Agency.”

During the past few years, the courts in Brazil have issued decisions holding that Article 229-C did not grant ANVISA the power to examine patent applications for compliance with the patentability requirements under the Statute. Moreover, these cases held that ANVISA was solely limited to determining whether or not a patent application was against public health according to Article 18, I of the Statute and nothing more.

The most favorable decisions for patent owners were issued by District Courts sitting in Brasilia. Specifically, several Courts issued preliminary injunctions ordering ANVISA to grant prior approval of patent applications claiming pharmaceutical inventions holding that the examination of patentability requirements by ANVISA was illegal (for example, in May 2015, the 15th Federal District Court granted a preliminary injunction requested by Novartis on a writ of mandamus filed against ANVISA).

However, on June 11, 2015, the Honorable Marcia Nunes de Barros of the 13th Federal District Court sitting in Rio de Janeiro denied a preliminary injunction and held that ANVISA was permitted to examine a patent application claiming pharmaceutical inventions for compliance with the patentability requirements. The case was filed by Abbvie, Inc. and related to two patent applications involving Kaletra® (lopinavir/ritonavir).

In a 30-page decision, the Judge described the importance of Article 229-C and ANVISA’s ability to examination patent applications for compliance with the patentability requirements under the Statute in order to avoid the patenting of inventions to merely “incremental innovations”. Specifically, the Judge stated that: “…taking into consideration the systematic element, it seems clear, as already exposed, that the goal of the rule that included ANVISA in the proceeding of deciding about pharmaceutical patents, was clearly to include a vision over public health during examination, in a way to avoid the granting of undue patents, with highlights to the incremental ones”.

Unfortunately, but not surprisingly, this unfavorable decision will be used by ANVISA with respect to currently pending and future filed patent applications. However, it is too soon to assess how this decision will impact the current framework relating to Article 229-C and ANVISA with respect to patent prosecution. This decision should be carefully analyzed and rebutted by patent owners in order to avoid what could be a potential game changer in the pharmaceutical sector that might negatively impact innovator companies in Brazil.

Patent owners should keep in mind that the Federal Courts sitting in Brasilia have traditionally been more inclined to hold that ANVISA cannot examine patent applications for compliance with patentability requirements. Hopefully, this decision will not impact Judges sitting in Brasilia.

This post was written by Lisa Mueller and Roberto Rodrigues of Licks Attorneys.